Many in Congress are Concerned about FDA’s Draft Rules Regarding Produce and Preventive Controls; Some Call for a Second Draft

In addition to the many (more than 20,000) comments to FDA on the draft rules regarding Produce and Preventive Controls implementing the Food Safety Modernization Act (“FSMA”) (Docket Nos. FDA-2011-N-0920 and FDA-2011-N-0921), FDA has received a flurry of letters from Congress – see here, here, here, and here – expressing concerns about the unintended effect of FDA’s draft rules on agriculture and small businesses and reminding FDA of the intent of FSMA.

Although the letters highlight different aspects, the common thread appears to be a concern that, if implemented as proposed, the rules will result in unintended consequences that will be severely detrimental to agriculture. The lawmakers’ concerns appear to relate primarily to FDA’s application of FSMA’s small business exemption and the proposed restrictions on the use of biological soil amendments and other conflicts between the proposed rules and current standards by USDA (e.g., the National Organic Program (“NOP”)). According to the lawmakers, the proposed rules fail to properly define small businesses that would be exempt from certain requirements. The proposed rules also fail to comply with FSMA’s mandate against establishing requirements that conflict with or duplicate the requirements of other laws and regulations, such as the NOP.

Some of the lawmakers suggest that FDA, rather than finalize the rules, revise the proposed rules and reissue them for public review and comment. However, in light of the court-ordered deadlines for finalizing the rules (see our previous post here), a “do-over” may not be feasible.